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REDWOOD CITY, Calif., May 14 /PRNewswire-FirstCall/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced positive results from the landmark QUASAR validation study, which demonstrated that the Oncotype DX(R) colon cancer test can independently predict individual recurrence risk in stage II colon cancer patients following surgery. Importantly, the Oncotype DX colon cancer Recurrence Score(R) provided additional independent clinical value beyond standard measures. The study showed that the colon cancer Recurrence Score maintained significance (p=0.008), independent of mismatch repair (MMR), also known as MSI (Microsatellite Instability), T-stage, nodes examined, grade and lymphovascular invasion.
These findings, which were selected from more than 4,000 accepted abstracts to be featured in the American Society of Clinical Oncology's (ASCO) advance presscast earlier today, address a large unmet need in the treatment of colon cancer by validating a clinical tool that can significantly improve risk assessment in the treatment planning for stage II colon cancer patients. Genomic Health announced these data in conjunction with ASCO's advance presscast presentation and subsequent embargo lift of all accepted abstracts today, and looks forward to the full data presentation at ASCO's annual meeting in Orlando, Florida on Saturday, May 30 at 3 p.m. ET.
'These clinical results represent an important advancement in bringing personalized medicine to the tens of thousands of people who suffer from stage II colon cancer, as the availability of precise markers to determine likelihood of recurrence risk are limited in today's clinical setting,' said David Kerr, M.D., DSc, professor of cancer medicine at the University of Oxford. 'With these results we have a validated multi-gene test to predict colon cancer recurrence that, when available, will enable physicians to better select patients for aggressive treatment beyond surgery.'
David Kerr, Richard Gray, Ph.D., professor of medical statistics at the University of Birmingham, and Philip Quirke, B.M., M.D. FRCPath, professor of pathology and tumor biology at the University of Leeds, are the principal investigators of the QUASAR validation study.
A second endpoint evaluating a separate score, with a distinct set of genes, designed to predict which patients experience greater proportional benefit of 5-fluorouracil/leucovorin (5FU/LV) following surgery was not met (p=0.19).
'The positive findings from the QUASAR validation study strongly support a new paradigm for assessing recurrence risk in stage II colon cancer, emphasizing the critical role of three measures, Recurrence Score, MMR/MSI and T-stage,' said Steve Shak, M.D., chief medical officer of Genomic Health.